Trial Outcomes & Findings for Carbohydrate Consumption as a Factor in Aspart Dosing (NCT NCT01333514)

Results Overview

Will determine if the probability of hypoglycemia in each arm; calculation details \[i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"\]

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

measured 4 times/day until completion of study an average of 2 days

Results posted on

2023-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Carbohydrate Based Prandial Insulin Dosing Subjects will received prandial insulin based on the amount of carbohydrates consumed. aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)	Usual Care Prandial Insulin Dosing Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. aspart: 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
Overall Study STARTED	8	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Carbohydrate Based Prandial Insulin Dosing Subjects will received prandial insulin based on the amount of carbohydrates consumed. aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)	Usual Care Prandial Insulin Dosing Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. aspart: 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Carbohydrate Consumption as a Factor in Aspart Dosing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carbohydrate Based Prandial Insulin Dosing n=8 Participants Subjects will received prandial insulin based on the amount of carbohydrates consumed. aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)	Usual Care Prandial Insulin Dosing n=6 Participants Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. aspart: 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 7.2 • n=5 Participants	70.4 years STANDARD_DEVIATION 9.4 • n=7 Participants	66 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: measured 4 times/day until completion of study an average of 2 days

Will determine if the probability of hypoglycemia in each arm; calculation details \[i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"\]

Outcome measures

Outcome measures
Measure	Carbohydrate Based Prandial Insulin Dosing n=7 Participants Subjects will received prandial insulin based on the amount of carbohydrates consumed. aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)	Usual Care Prandial Insulin Dosing n=6 Participants Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. aspart: 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
Probability of Hypoglycemia	0.025 probability	0.011 probability

SECONDARY outcome

Timeframe: blood sugars/4x day until completion of study, an average of 2 days

Will determine if the probability of hyperglycemia in each arm; calculation details \[i.e. "Experimental Event Rate (EER) = probability of outcome occurring in experimental group = a/(a+b)"\]

Outcome measures

Outcome measures
Measure	Carbohydrate Based Prandial Insulin Dosing n=7 Participants Subjects will received prandial insulin based on the amount of carbohydrates consumed. aspart: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)	Usual Care Prandial Insulin Dosing n=6 Participants Subjects will received prandial insulin if they consume 50% or more of their meal-tray as is the usual care. aspart: 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
Probability of Hyperglycemia	0.4 probability	0.329 probability

Adverse Events

Carbohydrate Based Prandial Insulin Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Prandial Insulin Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chung-Kay Koh

Rush University Medical Center

Phone: 8475305230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place